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CTRI Number  CTRI/2024/03/063653 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TWO DIFFERENT TYPES OF APPROCHES FOR BILATERAL QUADRATUS LUMBORUM BLOCK FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY 
Scientific Title of Study   BILATERAL QUADRATUS LUMBORUM BLOCK COMPARING POSTERIOR VS ANTERIOR APPROACH FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DALAL PRACHI KALPESHKUMAR 
Designation  Resident doctor (MD Anesthesiology) 
Affiliation  GMERS Medical College & hospital Gotri Vadodara 
Address  6th floor department of anaesthesiology GMERS medical college and hospital Gotri vadodara

Vadodara
GUJARAT
390021
India 
Phone  9638573373  
Fax    
Email  prachidalal96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anup Chandnani 
Designation  Professor and Head(MD anaesthesiology) 
Affiliation  GMERS medical college & hospital Gotri 
Address  6th floor department of anaesthesiology GMERS medical college and hospital Gotri vadodara

Vadodara
GUJARAT
390021
India 
Phone  9925436505  
Fax    
Email  anupchandnani29@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dalal Prachi Kalpeshkumar 
Designation  Resident doctor (MD Anesthesiology) 
Affiliation  GMERS Medical College & hospital Gotri Vadodara 
Address  6th floor department of anaesthesiology GMERS medical college and hospital Gotri vadodara

Vadodara
GUJARAT
390021
India 
Phone  9638573373  
Fax    
Email  prachidalal96@gmail.com  
 
Source of Monetary or Material Support  
GMERS Hospital, Gotri, Vadodara 
 
Primary Sponsor  
Name  GMERS Hospital 
Address  Old TB campus, gotri main road, gotri, vadodara 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prachi Dalal  GMERS Hospital  6th FLOOR, DEPARTMENT OF ANESTHESIOLOGY, GMERS MEDICAL COLLEGE AND HOSPITAL CAMPUS, GOTRI
Vadodara
GUJARAT 
9638573373

prachidalal96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC GMERS medical college and hospital, Gotri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  USG GUIDED BILATERAL QUADRATUS LUMBORUM POSTERIOR APPROACH  The procedure will be performed bilaterally on each patient in lateral position under all aseptic and antiseptic precaution. The transducer will be placed transverse position cranial to iliac crest at the level of posterior axillary line. The needle will be inserted in plane from posterior to anterior trajectory until needle tip penetrated posterior to QL muscle inj. Ropivacaine (0.25%) 20 ml will be injected posterior to the lateral edge of the QL muscle, between QL muscle and erector spinae muscle within the middle layer of thoracolumbar fascia after negative aspiration of blood within 20 minutes with maximum 2 attempts 
Comparator Agent  USG GUIDED BILATERAL QUADTRATUS LUMBORUM ANTERIOR APPROACH   The procedure will be performed bilaterally on each patient in lateral position under all aseptic and antiseptic precaution. The transducer will be placed transverse position cranial to iliac crest at the level of posterior axillary line. The needle will be inserted in plane from posterior to anterior trajectory until needle tip penetrated in anterior part of QL muscle. 20 ml of 0.25% inj. Ropivacaine will be injected after negative aspiration of blood between the QL and psoas muscle within 20 minutes with maximum 2 attempts 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients posted for laparoscopic cholecystectomy surgery consenting for administration of QL block post operatively
2)Patients aged between 18 to 60 years
3)Patients with BMI ranging between 19-30 kg per m2
4)Patients with American society of anaesthesia physical status I and II
 
 
ExclusionCriteria 
Details  1)Infection at local site
2)History of allergic reaction to study drugs
3)Patients on chronic pain medication
4)Altered coagulation profile
5)History of known lower limb muscle weakness
6)Known systemic disease pertaining CVS, Respiratory, psychiatric, central nervous system, renal, liver, musculoskeletal system
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The time to the requirement of first rescue analgesia   The time to the requirement of first rescue analgesia observed in the study groups via visual analogue score at rest(end of surgery 30 minutes, 2nd, 6th, 12th, 24th hour)  
 
Secondary Outcome  
Outcome  TimePoints 
The total consumption of analgesics in postoperative period
 
The total consumption of analgesics in postoperative period up to 24 hours  
the difference in duration of procedure time  the difference in duration of procedure time in minutes  
Patient’s vital parameters stability  Patient’s vital parameters stability till 24 hours 
patient satisfaction score   patient satisfaction score till 24 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   16/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM OF STUDY

  To compare postoperative analgesic duration of ultrasound guided Two types of QL block (posterior QL  Vs Anterior QL) using inj. Ropivacaine 0.25% in laparoscopic cholecystectomy surgeries

OBJECTIVES

PRIMARY OBJECTIVE

·       To compare the duration of post operative analgesia of ultrasound guided bilateral two type of QL block with  inj. Ropivacaine (0.25%)

 

SECONDARY OBJECTIVE

Total consumption of systemic analgesics 24 hour postoperatively

Ease of administration of two blocks

Safety of block

Patient’s satisfaction score

 

STUDY PROTOCOL

   ETHICAL CONSIDERATION: this study will be conducted after obtaining ethical approval by local ethical committee of GMERS MEDICAL COLLEGE AND HOSPITAL, Vadodara and topic being registered with CTRI (clinical trial registry of India)

  STUDY DESIGN: Prospective Randomized control, double blind clinical study with allocation concealment and a uniform allocation sequence

   STUDY PLACE: General surgery operating unit in a tertiary care teaching hospital( GMERS Medical college and Hospital, Vadodara)

  STUDY PERIOD: over the period 6-10 months after the approval from ethical committee

     STUDY POPULATION: Adults consenting for administration of QL block posted for laparoscopic cholecystectomy surgery with comparable demographic profile

 

   INCLUSION CRITERIA:

      Patients posted for laparoscopic cholecystectomy surgery consenting for administration of QL block post operatively

      patients aged between 18 to 60 years

      patients with BMI ranging between 19- 30 kg/m2

      patients with American society of anesthesia physical status I and II

 

 

EXCLUSION CRITERIA:

       Infection at local site

       History of allergic reaction to study drugs

       Patients on chronic pain medication

       Altered coagulation profile

       History of known lower limb muscle weakness

  Known systemic disease pertaining CVS, Respiratory, psychiatric, central nervous system, renal, liver, musculoskeletal system

METHODOLOGY

After proper informed written consent, patients of ASA- I & II physical status posted for Laparoscopic cholecystectomy Surgeries will be recruited to participate in the study To ensure equality of randomization, each patient will be randomly assigned after considering inclusion/exclusion criteria, using concealed opaque envelope method by consultant in Department of Anesthesia, into either

Group P: Posterior Quadratus lumborum muscle block

Group A: anterior Quadratus lumborum muscle block

 

      The study will be single blinded randomized clinical study with Patient receiving block  will be blinded to the type of block


METHOD 

Thorough preanesthetic Evaluation done prior to day of surgery to give the final fitness Following the routine protocol for General Anesthesia, patient will be anesthetized under General Anesthesia after proper premedication, routine induction agent and muscle relaxant, securing the airway with endotracheal tube and maintained preoperatively with mechanical ventilation  At the end of the surgery QL block will be administered under USG guidance (low frequency curvilinear probe of 3-5 Hz) bilaterally by a trained Anesthesiologist. Inj. paracetamol 1 gm iv given half hour before extubation

 

USG GUIDED ANTERIOR QUADRATUS LUMBORUM BLOCK

·       The procedure will be performed bilaterally on each patient in lateral position under all aseptic and antiseptic precaution The transducer will be placed transverse position cranial to iliac crest at the level of posterior axillary line The needle will be inserted in plane from posterior to anterior trajectory until needle tip penetrated in anterior part of QL muscle 20 ml of 0.25% inj. Ropivacaine will be injected after negative aspiration of blood between the QL and psoas muscle

 

USG GUIDED POSTERIOR QUADRATUS LUMBORUM BLOCK

   The procedure will be performed bilaterally on each patient in lateral position under all aseptic and antiseptic precaution. The transducer will be placed transverse position cranial to iliac crest at the level of posterior axillary line The needle will be inserted in plane from posterior to anterior trajectory until needle tip  penetrated posterior to QL muscle inj. Ropivacaine (0.25%) 20 ml will be injected posterior to the lateral edge of the QL muscle, between QL muscle and erector spinae muscle within the middle layer of thoracolumbar fascia after negative aspiration of blood

Procedure Time will be noted from time of inserting needle on one side to removal of needle on the contralateral side after administration of block Patient will be shifted to PACU for observation

ASSESSMENT OF ANALGESIA:

The analgesic effect of block will be assessed using VAS score at rest (end of surgery 30th minute, 2nd , 6th , 12th and 24th hour), during activity up to 24 hours by an observer who is blinded to the type of block given

If any point of time VAS is more than equal to 4 inj. Tramadol 100 mg intravenously will be given as rescue analgesia there after inj. tramadol 100 mg will be administered round the clock till 24 hours of observation. Total duration of analgesia will be considered from T0 (time of completion of administration of QL block) to first rescue analgesia will be given Total consumption of rescue analgesic drug during the period observation will be documented

OUTCOME MEASURES

  PRIMARY OUTCOME: The time to the requirement of first rescue analgesia observed in the study groups becomes the primary outcome of this study

  SECONDARY OUTCOME: The total consumption of analgesics in postoperative period up to 24 hours forms the secondary outcome Also the difference in duration of procedure time and Patient’s vital parameters stability and patient satisfaction score graded as poor, fair, Good, excellent will be observed till 24 hours  


 
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